MENTHOL 5% by Advanced Rx of Tennessee, LLC MENTHOL 5% patch

MENTHOL 5% by

Drug Labeling and Warnings

MENTHOL 5% by is a Otc medication manufactured, distributed, or labeled by Advanced Rx of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS (IN EACH PATCH)

Menthol 5%

USES

Temporary relief from minor aches and pains of sore muscles and joints

associated with:

• arthrits
• backache
• strains
• sprains

PURPOSE

External Analgesic

WARNINGS

For external use only.

CONSULT WITH A DOCTOR OR PHARMACIST BEFORE CONTINUED USE IF YOU HAVE

Sensitive Skin

WHEN USING THIS PRODUCT

• Use only as directed
• Do not bandage tightly or use with heating pad or device
• Avoid contact with the eyes or mucous membranes
• Do not apply to wounds or damaged skin
• Do not use with other ointments,creams,sprays, or liniments
• Do not apply to irritated skin
• Store in a cool, dry place away from sunlight

STOP USE AND ASK A DOCTOR IF

Burning discomfort or excessive skin irritation develops, condition wrosens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

IF YOU ARE PREGNANT OR BREAST-FEEDING

IF YOU ARE PREGNANT OR BREAST-FEEDING: Consult with physician before use of this product.

KEEP OUT OF THE REACH OF CHILDREN

If accidentally ingested, get medical help or contact a Poison Control Center immediately

DIRECTIONS:

Adults and Children 12 Years of Age or Over:Clean and dry the affected area, partially peel back the protective film and apply the exposed patch to the site of pain. Carefully remove the remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

Children Under 12 Years of Age:Consult physician.

OTHER INGREDIENTS

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sodium Polyacrylate, Titanium dioxide, Water

QUESTIONS?

Call toll-free: (307) 410-3813 or Email: info@marcellahealth.com

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MENTHOL 5% 
menthol 5% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0543(NDC:85096-301)
Route of Administration	TRANSDERMAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W)	MENTHOL, (+)-	500 mg  in 10 g

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMELLIA SINENSIS LEAF (UNII: W2ZU1RY8B0)
POVIDONE K90 (UNII: RDH86HJV5Z)
PETROLATUM (UNII: 4T6H12BN9U)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
KAOLIN (UNII: 24H4NWX5CO)
TARTARIC ACID (UNII: W4888I119H)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
CELLULOSE GUM (UNII: K679OBS311)
FRANKINCENSE (UNII: R9XLF1R1WM)
MINERAL OIL (UNII: T5L8T28FGP)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80425-0543-1	30 in 1 BOX	08/08/2025
1		11 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	08/08/2025

Labeler - Advanced Rx of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx of Tennessee, LLC		117023142	repack(80425-0543)